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Neurofeedback for Bipolar Disorder (NEUROFEED-BD)

Primary Purpose

Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Real-time fMRI Neurofeedback
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, Neurofeedback, fMRI, Residual symptoms, Emotion, Cognitive training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with bipolar disorder I or II (DSM-5 criteria); Aged between ≥ 18 and ≤ 65; Absence of major mood episode for at least 3 months before inclusion (MADRS scores < 12; YMRS score < 10); Presence of residual depressive symptoms, as assessed by the MADRS (score > 5); Stabilized dose of mood stabilizer medication for at least 3 months before inclusion. Written consent Affiliation to a social security system Effective contraception for women of childbearing age Exclusion Criteria: Severe physical disorders that may be life-threatening; Major psychiatric (Axis 1) comorbidities except for anxiety disorders; Any current substance abuse except for tobacco or cannabis. Substance abuse will be defined by the DSM V criteria; Exclusion criteria applicable to MRI Panic disorder, claustrophobia, epilepsy Pace maker or neuronal stimulator, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, non removable removable magnetizable metallic material Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy, dementia...); Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social Rhythm Therapy - IPSRT) as well as brain stimulation techniques (Electroconvulsive Therapy - ECT, Transcranial Magnetic Stimulation - TMS, Deep Brain Stimulation - DBS); Subject included in clinical and / or therapeutic experimentation in progress. Patients under legal protection Prisoners Pregnancy Breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Active feedback

    Sham feedback

    Arm Description

    Group receiving "real" neurofeedback (NFB) (activity of the emotional brain network)

    Group receiving "sham" NFB (activity from brain regions not implicated in emotion processing) to control for a potential placebo effect.

    Outcomes

    Primary Outcome Measures

    Changes in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
    Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.

    Secondary Outcome Measures

    Montgomery and Asberg Depression Rating Scale (MADRS)
    Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    Young Mania Rating Scale (YMRS)
    Evaluation of manic symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    Bipolar Depression Rating Scale (BDRS)
    Evaluation of bipolar depression. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    State-Trait Anxiety Inventory (STAI A-B)
    Evaluation of trait and state anxiety. Total score ranging from 20 to 80 for both subscales, with higher scores indicating a greater severity of symptoms.
    Multidimensional Assessment of Thymic States - MAThyS
    Evaluation of thymic state. Total score ranging from 0 to 200, lower scores indicate general inhibition, and higher scores indicate general excitation. A more descriptive approach can be done by analysing the sub-score.
    Affective Intensity Measure - AIM
    Evaluation of emotion reactivity. Total score ranging from 20 to 120, with higher scores indicating higher strength or intensity of people's emotional experiences.
    Affective Lability Scale - ALS
    Evaluation of mood lability. Total score ranging from 0 to 162, with higher scores indicating greater affective lability.
    Cognitive Emotion Regulation Questionnaire - CERQ
    Evaluation of emotion regulation abilities. Subscales scores ranging from 4 to 20, with higher subscale scores indicating greater use of a specific cognitive strategy.
    Quality of life scale - QOLS
    Quality of life assessment. Score ranging from 1 to 5, 5 indicating better quality of life
    Five Facets Mindfulness Questionnaire - FFMQ
    Evaluation of trait mindfulness. Total score ranging from 39 to 195, higher scores are indicative of someone who is more mindful in their everyday life
    Global functioning assessment - GAF scale
    Evaluation of global functioning. Total score ranging from 0 to 100, higher scores indicating better global functioning.
    Questionnaire of Adherence to the technology
    Evaluation of the score of the acceptability of neurofeedback. Total score ranging from 6 to 42, higher scores indicating better acceptability of the technology.
    Self-efficacy scale
    Evaluation of personal efficiency. Total score ranging from 21 to 105, higher scores indicating stronger belief that one's actions are responsible for successful outcomes.
    The Ekman facial recognition test
    Emotion recognition evaluation. Cognitive task
    The affective bias task
    Evaluation of emotional bias. Cognitive task
    The Test battery for Attentional Performance (TAP)
    Evaluation of attention. Cognitive task
    The choice reaction task
    Evaluation of mindwandering, meta-awareness and ruminations. Cognitive task
    MRI T1-T2 weighted scan
    Evaluation of grey and white matter (micro)structure. MRI measurement
    MRI diffusion weighted scan
    Evaluation of grey and white matter (micro)structure. MRI measurement
    functional MRI resting-state scan
    Evaluation of brain functional connectivity. MRI measurement

    Full Information

    First Posted
    February 28, 2023
    Last Updated
    March 27, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05802446
    Brief Title
    Neurofeedback for Bipolar Disorder
    Acronym
    NEUROFEED-BD
    Official Title
    Real-time fMRI Neurofeedback as Treatment for Inter-critical Mood Symptoms in Bipolar Disorder : a Randomized Controlled Multicentric Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Bipolar Disorder (BD) is a severe mood disorder affecting between 1% and 3% of the general population. It is characterized by the succession of depressive and manic episodes, with periods of stabilization during which patients may present "residual" depressive or anxious symptoms, which are characterized by sadness and emotional hyper-reactivity. Although subthreshold, these residual symptoms are very disabling for their daily lives and are associated with the risk of recurrence and poor global functioning. The effect of pharmacological and psychotherapeutic treatments is demonstrated in the management of acute episodes but remains insufficient on residual symptoms. Therefore, there are so far few therapeutic options to target the inter-episode residual symptoms in BD. One novel approach is the real-time functional magnetic resonance imaging (fMRI) neurofeedback (NFB), which has already been shown to be an efficient method for self-regulating brain function, behavior and treating depression. Hypothesis/Objective : This study aims at assessing the efficacy of 3-weeks neurofeedback training with real-time fMRI on the treatment of residual mood symptoms in patients with BD. The investigators will specifically target depressive symptoms by training the patients to regulate the emotional network hemodynamic response to emotional stimuli. Method : The investigators will include 64 stabilized patients with BD. The investigators will recruit them in three French expert centers for BD and will randomly assign them to the experimental group, receiving feedback from the emotional brain network hemodynamic activity, or to the control group, receiving the signal from control brain areas not involved in emotion processing. Both groups will be trained to regulate their brain activity while they are presented with negatively valenced emotional pictures, based on the neurofeedback shown immediately after the trial. They will continue their usual treatment (as prescribed) throughout the duration of the study. Clinical scales and cognitive tests will enable us to evaluate the symptomatic, emotional, and cognitive changes after NFB training. The investigators will also measure resting-state functional connectivity and brain morphology before and after NFB to assess brain plasticity and to explore the neural mechanisms associated with successful regulation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder
    Keywords
    Bipolar disorder, Neurofeedback, fMRI, Residual symptoms, Emotion, Cognitive training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active feedback
    Arm Type
    Experimental
    Arm Description
    Group receiving "real" neurofeedback (NFB) (activity of the emotional brain network)
    Arm Title
    Sham feedback
    Arm Type
    Sham Comparator
    Arm Description
    Group receiving "sham" NFB (activity from brain regions not implicated in emotion processing) to control for a potential placebo effect.
    Intervention Type
    Other
    Intervention Name(s)
    Real-time fMRI Neurofeedback
    Intervention Description
    Neurofeedback with real-time fMRI is a recent technique that allows to record the BOLD signal from a particular brain region and to display it back in real-time to the participant. With this feedback on brain activity, subjects can learn to control the activity of selected brain areas. Trial after trial, participants develop their individual strategies to voluntarily regulate the signal. The main objective of the neurofeedback training is that the participant develops an enhanced ability to exert control over activity in the target area(s) even without feedback. By manipulating targeted brain circuits, this training can induce modifications in particular behaviors and promote selective plasticity within the corresponding brain networks.
    Primary Outcome Measure Information:
    Title
    Changes in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
    Description
    Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    Time Frame
    Baseline, 3 weeks.
    Secondary Outcome Measure Information:
    Title
    Montgomery and Asberg Depression Rating Scale (MADRS)
    Description
    Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Young Mania Rating Scale (YMRS)
    Description
    Evaluation of manic symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Bipolar Depression Rating Scale (BDRS)
    Description
    Evaluation of bipolar depression. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    State-Trait Anxiety Inventory (STAI A-B)
    Description
    Evaluation of trait and state anxiety. Total score ranging from 20 to 80 for both subscales, with higher scores indicating a greater severity of symptoms.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Multidimensional Assessment of Thymic States - MAThyS
    Description
    Evaluation of thymic state. Total score ranging from 0 to 200, lower scores indicate general inhibition, and higher scores indicate general excitation. A more descriptive approach can be done by analysing the sub-score.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Affective Intensity Measure - AIM
    Description
    Evaluation of emotion reactivity. Total score ranging from 20 to 120, with higher scores indicating higher strength or intensity of people's emotional experiences.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Affective Lability Scale - ALS
    Description
    Evaluation of mood lability. Total score ranging from 0 to 162, with higher scores indicating greater affective lability.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Cognitive Emotion Regulation Questionnaire - CERQ
    Description
    Evaluation of emotion regulation abilities. Subscales scores ranging from 4 to 20, with higher subscale scores indicating greater use of a specific cognitive strategy.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Quality of life scale - QOLS
    Description
    Quality of life assessment. Score ranging from 1 to 5, 5 indicating better quality of life
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training. .
    Title
    Five Facets Mindfulness Questionnaire - FFMQ
    Description
    Evaluation of trait mindfulness. Total score ranging from 39 to 195, higher scores are indicative of someone who is more mindful in their everyday life
    Time Frame
    Baseline, 3 weeks and 4, 8 weeks after the end of the training.
    Title
    Global functioning assessment - GAF scale
    Description
    Evaluation of global functioning. Total score ranging from 0 to 100, higher scores indicating better global functioning.
    Time Frame
    Baseline, 3 weeks, and 4, 8 weeks after the end of the training.
    Title
    Questionnaire of Adherence to the technology
    Description
    Evaluation of the score of the acceptability of neurofeedback. Total score ranging from 6 to 42, higher scores indicating better acceptability of the technology.
    Time Frame
    Baseline, 3 weeks.
    Title
    Self-efficacy scale
    Description
    Evaluation of personal efficiency. Total score ranging from 21 to 105, higher scores indicating stronger belief that one's actions are responsible for successful outcomes.
    Time Frame
    Baseline, 3 weeks.
    Title
    The Ekman facial recognition test
    Description
    Emotion recognition evaluation. Cognitive task
    Time Frame
    Baseline, 3 weeks.
    Title
    The affective bias task
    Description
    Evaluation of emotional bias. Cognitive task
    Time Frame
    Baseline, 3 weeks.
    Title
    The Test battery for Attentional Performance (TAP)
    Description
    Evaluation of attention. Cognitive task
    Time Frame
    Baseline, 3 weeks.
    Title
    The choice reaction task
    Description
    Evaluation of mindwandering, meta-awareness and ruminations. Cognitive task
    Time Frame
    Baseline, 3 weeks.
    Title
    MRI T1-T2 weighted scan
    Description
    Evaluation of grey and white matter (micro)structure. MRI measurement
    Time Frame
    Baseline, 3 weeks
    Title
    MRI diffusion weighted scan
    Description
    Evaluation of grey and white matter (micro)structure. MRI measurement
    Time Frame
    Baseline, 3 weeks
    Title
    functional MRI resting-state scan
    Description
    Evaluation of brain functional connectivity. MRI measurement
    Time Frame
    Baseline, 3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with bipolar disorder I or II (DSM-5 criteria); Aged between ≥ 18 and ≤ 65; Absence of major mood episode for at least 3 months before inclusion (MADRS scores < 12; YMRS score < 10); Presence of residual depressive symptoms, as assessed by the MADRS (score > 5); Stabilized dose of mood stabilizer medication for at least 3 months before inclusion. Written consent Affiliation to a social security system Effective contraception for women of childbearing age Exclusion Criteria: Severe physical disorders that may be life-threatening; Major psychiatric (Axis 1) comorbidities except for anxiety disorders; Any current substance abuse except for tobacco or cannabis. Substance abuse will be defined by the DSM V criteria; Exclusion criteria applicable to MRI Panic disorder, claustrophobia, epilepsy Pace maker or neuronal stimulator, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, non removable removable magnetizable metallic material Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy, dementia...); Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social Rhythm Therapy - IPSRT) as well as brain stimulation techniques (Electroconvulsive Therapy - ECT, Transcranial Magnetic Stimulation - TMS, Deep Brain Stimulation - DBS); Subject included in clinical and / or therapeutic experimentation in progress. Patients under legal protection Prisoners Pregnancy Breastfeeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Josselin HOUENOU, Professor (MD, PhD)
    Phone
    (+33)1 49 81 30 51
    Email
    josselin.houenou@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pauline Favre, Associate researcher (PhD)
    Phone
    (+33)1 69 08 24 81
    Email
    pauline.favre@cea.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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    Neurofeedback for Bipolar Disorder

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